| Date Initiated by Firm | December 09, 2022 |
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| Date Posted | January 20, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1000-2023 |
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| Recall Event ID |
91383 |
| 510(K)Number | K051602 K992660 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF |
|---|
| Code Information |
All serial numbers
1) AXIOM Luminos TF, Material #10093902 (no UDI)
2) AXIOM Iconos R100, Material #05895151 (no UDI)
3) AXIOM Iconos R200 C69, Material #10093961 (no UDI)
4) AXIOM Iconos R200 C20, Material #10093962 (no UDI)
5) AXIOM Luminos dRF, Material #10094200 (no UDI) |
| FEI Number |
2240869
|
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact | Rebecca Tudor
610-219-4834 |
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Manufacturer Reason
for Recall | There is potential for the footrest to detach from the patient table during use. |
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FDA Determined
Cause 2 | Process control |
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| Action | A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system. |
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| Quantity in Commerce | 654 units |
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| Distribution | Worldwide distribution |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
|
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